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Valproic Acid in Subjects With Intact Cognition - Proof of Concept Study

NCT01729598 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2019-10-09

Study results available
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Summary

The purpose of this study is to evaluate the safety of administration and effects of valproic acid on clusterin expression in cognitively-intact, healthy, elderly subjects. Clusterin mutations have recently been identified as a risk factor for the development of Alzheimer's Disease and changes in clusterin expression are seen in the elderly who develop Alzheimer's disease irrespective of whether they carry these genetic mutations or not. Valproic acid may prevent or reverse these changes.

Fourteen subjects with normal memory and thinking will participate in this study. Ten of these subjects will receive valproic acid and 4 will receive a "placebo" capsule with no active medicine. Participants will take study medication or placebo for 28 days and be followed for a total 35 days in this trial.

Conditions

Interventions

DRUG

Valproic Acid

generic valproic acid tablets packaged in placebo-matched capsules.

DRUG

Placebo

Placebo capsule without active study medication in identical capsules as experimental medicine.

Sponsors & Collaborators

  • University of Kentucky

    collaborator OTHER

  • Kentucky Alzheimer's Center

    collaborator UNKNOWN

  • Gregory Jicha, 323-5550

    lead OTHER

Principal Investigators

  • Steve Estus, PhD · University of Kentucky

  • Gregory Jicha, MD · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01729598 on ClinicalTrials.gov